The United States Pharmacopeia (USP) is an independent, science-based public health organization. USP's contributions to public health are enriched by the participation and oversight of expert volunteers representing pharmacy, medicine, and other healthcare professions as well as academia, government, the pharmaceutical industry, health plans, and consumer organizations.
In December 2003, the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) was signed into law. Under MMA, part D plans are required to cover prescription drugs within each therapeutic category and class of covered part D drugs. Per the MMA, USP is tasked to develop, in consultation with pharmaceutical benefit managers and other interested parties, a list of categories and classes that may be used by prescription drug plans and to revise such classification from time to time to reflect changes in therapeutic uses of covered Part D drugs and the additions of new covered Part D drugs.
The methodology for the USP Medicare Model Guidelines remains focused on two objectives:
1. Conducting a clinically based review and incorporation of Part D drugs (as defined in 42 CFR 423.1001)
2. Updating the USP Categories and Classes as necessary to accommodate changes in therapeutic uses and the additions of new Part D drugs, as specified in ¿1860D-4(b)(3)(C)(ii) of the Social Security Act
The USP Categories and Classes are developed utilizing contemporary scientific information and expert evaluation and aim to strike a balance of assuring Part D beneficiary access to safe and effective drugs that they need with the flexibility that Plans need to offer an affordable and effective benefit. This balance creates the taxonomy of the USP Medicare Model Guidelines, which are distinctly different in philosophy and structure than other taxonomy systems classifying drugs solely based upon either pharmacology or therapeutics.